Catheter guidewire and flushing apparatus and method of insertion

ABSTRACT

A flushing device comprises a catheter guidewire flushing apparatus comprising a connector having an insertion port, an outlet port and a flushing port. The invention allows a clinician to adjust the length of a catheter, to insert the catheter while flushing to maneuver the catheter through a tortuous blood vessel, and to easily remove the guidewire for safe disposal. The catheter can then be left in place in the blood vessel.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to the field of medical devices, andmore particularly pertains to the field of catheter guidewire andflushing apparatus.

2. Description of the Prior Art

Peripherally inserted catheters have long been used to access thevascular system because they provide a means of repeated access withoutcausing trauma or pain to the patient. Additionally, when long termvascular access is required (greater then two weeks) a catheter shouldbe used because the alternative, multiple injections, can cause patientdiscomfort and lead to vein deterioration. When peripheral catheters areinstalled in a patient's extremity, they are left in the vein andtherefore a portion protrudes through the skin for access. These priorart catheters were short (approximately one to one and one-half inches).Their short length results in migration into and out of the vein, anundesired occurrence. This migration provides an opening for infectiousagents to enter the vascular system which has led to seriouscomplications. Because of this, peripheral intravascular catheters wereusually changed every two to three days. In certain circumstances, theywere replaced daily.

Peripherally inserted central catheters, or PICCs, were developed toalleviate some of the problems associated with long-term vascular accessusing short-term peripheral catheters. The PICC is a much longercatheter designed to be inserted percutaneously such that it reachesdeep into the vascular system. The end of the catheter is usually placedin the superior vena cava of the heart to utilize the larger bloodvolume in that chamber as a diluent for the medication beingadministered. PICCs are becoming the device of choice for providingaccess to a patient's vascular system for therapeutic support such aschemotherapy, antibiotic treatment, chemical environment monitoring andintravenous medication.

To place the end of the PICC in the heart, one must be able to navigatethe tortuous venous path, which includes many natural blockades (e.g.,venous valves). The catheter must be soft and pliable for navigation andcomfort. It must also be constructed of biocompatible materials becauseof the long indwelling period. Catheters having these characteristicsare usually manufactured of medical grade polyurethane or siliconerubber, both of which can be made very soft and pliable.

PICC lines made of these soft pliable materials are very difficult andtime consuming to install. Their pliant construction allows them tocollapse and bend making insertion tedious. Often, it can take up to onehour to insert one catheter, time most clinicians do not have. This alsoincreases the cost of health care.

To ease the difficulty of installation, a flexible metal stylet, orguidewire, is used as a means of stiffening the catheter for insertion.Once the catheter is inserted, the guidewire is removed, leaving thesoft, pliable, catheter in the desired position. The two most commonguidewire types are of a coiled spring or twist-braided wireconstruction.

The use of guidewires, however, causes their own problems. A firstproblem is that friction between the guidewire and catheter inner-wallincreases the difficulty of removing the guidewire. The tortuous routethe catheter takes in order to reach its final destination causes bendsin the catheter guidewire apparatus forcing the guidewire against theinner wall. To reduce this friction, some manufacturers have coatedtheir guidewires with a teflon (PTFE) material, adding some lubricityand thereby reducing the friction between the guidewire and the catheterinner-wall. A second approach to reducing friction is to coat theguidewire with hydrophilic silicone. Such coatings provide lubricatingsurfaces when they become wet. Both of these methods, which requirecoating the guidewire, are useful on either the coiled spring or thetwist-braided guidewire.

A second problem involved with the use of guidewires is the potentialfor vessel perforation if the end of the guidewire is forced against thevessel wall. To reduce this danger, coiled spring wires use a softflexible tip while twist-braided wires have a spherical ball affixed totheir ends.

No matter what type of guidewire is used, it is recommended that thecatheter be flushed with an aqueous solution before, during, and aftercatheter insertion. The catheter guidewire apparatus is flushed prior topatient installation in order to check for catheter patency. Thecatheter is flushed during installation to help maneuver it through thetortuous venous path and to prevent blood from entering the PICC andclotting (an occurrence which makes guidewire removal difficult orimpossible). The catheter is flushed after installation in order tofacilitate removal of the guidewire. Therefore, there is a need for anapparatus that allows for safe, convenient and economical flushing ofcatheter guidewire systems before, during and after insertion.

Prior art catheter guidewire apparatus' recommended that the userinstall the guidewire so that it emerges a little, approximatelyone-half of one centimeter beyond the end of the catheter. This is forflushing purposes and to provide the user with a portion to hold whenremoving the guidewire. Traditionally, when flushing a catheter that hasa guidewire installed therein, a syringe is connected to the catheter byplacing the exposed portion of the guidewire into the tip of the syringeand fastening the syringe to the catheter's fitting. While this methodprovides a way to supply liquid a interface between the catheter and theguidewire, it has several disadvantages. With this method, the exposedportion of the guidewire is actually inserted inside the syringe'sbarrel. During flushing, the syringe's plunger naturally moves furtherinto the barrel. A major disadvantage of this system is that thedepressing plunger is prone to striking that portion of the guidewirethat is within the syringe's barrel. In such a situation, the plungerthen may push the guidewire further into the catheter causing theguidewire to actually emerge from the end of the catheter that is deepwithin a patient. When this occurs, the guidewire, which is now exposedin the patient, can puncture vital organs of the patient such as a lungor a major vein.

This traditional method also does not work well when the catheter istrimmed to length (catheters are made to standard lengths which may belonger than needed to ensure that the tip is installed at the mostdesirable site). Since the guidewire has a special tip on its end, asdiscussed above, it is usually not cut and therefore the guidewire mustbe partially withdrawn prior to trimming. In this situation, there willbe considerably more than the normal length of guidewire emerging fromthe end of the catheter. This excess length of guidewire cannot beinserted in the syringe barrel, thereby preventing the syringe frombeing placed over the syringe's female luer for flushing. This is amajor disadvantage of the prior art.

Some manufacturers suggest that post-catheter shortening flushing whenexcess guidewire emerges from the female hub can be accomplished byforcing the syringe tip alongside the wire in the end of the catheter,thereby bending the guidewire to the side of the catheter end. A majordisadvantage to forcing the syringe in the catheter's end with theguidewire bent away from the syringe's luer is that in such anarrangement there will be no seal between the catheter and the syringe.An incomplete seal will lead to leaks which will prevent adequateflushing. Therefore, since prior art devices are extremely difficult toflush once the catheter has been shortened, guidewire removal, which isa critical requirement of catheter guidewire systems, has been verydifficult and a better system and method is needed.

The present invention overcomes the problems associated with prior artcatheter guidewire flushing apparatus. The invention allows the user toflush the catheter before using it to check catheter patency, to flushthe catheter during insertion to help maneuver around venousobstructions, to flush the catheter after placement for guidewireremoval, to leave the guidewire in place to help visibility whenchecking placement position radio graphically and to be able to trim acatheter and still maintain a seal between a syringe and the catheter.

SUMMARY OF THE INVENTION

The present invention overcomes the problems and disadvantages of theprior art through the use of a unique catheter assembly comprising aconnector. The preferred connector comprises a three-way connector thatcomprises an insertion port, a outlet port and a flushing port. Theinsertion port is preferably collinear with the outlet port andpreferably a reclosable septum covers the insertion port.

The assembly of the present invention preferably comprises aperipherally inserted catheter that is connected to the outlet port. Ahydrophilic stylet is slidably disposed such that it extends through theinsertion port and outlet port so that the stylet enters the catheter,thereby stiffening it for venous introduction. A plastic handle may beaffixed to the distal end of the stylet to provide a means for styletmanipulation and to prevent stylet migration.

A preferred method of using the catheter assembly comprises preparingthe assembly for insertion, inserting the catheter and removing thestylet. If desired, the method may include the step of verifying theposition of the catheter. The method of preparation comprises theattaching of a syringe filled with a heparin or normal saline solutionto the flushing port of the connector, flushing the catheter to checkfor patency and to remove excess air, adjusting, if desired, the lengthof the catheter by withdrawing a portion of the stylet from the cathetersuch that only the desired length of catheter has the stylet within it,and removing the unwanted portion of the catheter.

After any necessary trimming, the catheter is ready for installation ina patient. The method of insertion comprises flushing with the syringe(which is still attached to the flushing port) if undue resistance isfelt due to any venous obstructions. This flushing helps to deflect thetip of the catheter to help ease it past the obstruction. Theverification step comprises leaving the guidewire in place,radiographically detecting the stylet, and flushing the catheter bysimply depressing the syringe's plunger as needed. The method of removalof the guidewire comprises pulling the guidewire handle to move theguidewire out of the catheter. The catheter is flushed if resistance ismet when removing the guidewire by depressing the syringe's plunger.

The above and other features of the invention, including various noveldetails of construction and combination of parts, will now be moreparticularly described with reference to the accompanying drawings andpointed out in the claims. It will be understood that the particulardevices embodying the invention are shown by way of illustration onlyand not as limitations of the invention. The principles and features ofthis invention may be employed in various and numerous embodimentswithout departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference is made to the accompanying drawings in which are shownillustrative embodiments of aspects of the invention, from which itsnovel features and advantages will be apparent to those skilled in theart.

FIG. 1 is a side view of an embodiment of a vascular catheter guidewireflushing apparatus in accordance with the present invention.

FIG. 2 is an enlarged sectional view of the embodiment of FIG. 1 whichshows the catheter guidewire flushing apparatus' three-way connector,septum, and guidewire.

FIG. 3 is a view of catheter trimming technique.

BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to the drawings, and in particular FIGS. 1 and 2, there isseen an embodiment of a catheter guidewire flushing apparatus 10 of theinvention. The guidewire flushing apparatus comprises a three-wayconnector 15 that comprises an insertion port 18, a outlet port 21 and aflushing port 24. The insertion port 18, outlet port 21 and flushingport 24 are preferably integral to each other and form a cavity.

A peripherally inserted central catheter, or PICC, 30 comprises a femalehub 28 and a catheter 33. The female hub 28 and catheter 33 are fastenedtogether to form a continuous and leakless assembly. The catheter 33 canbe constructed of any suitable material, such as medical gradepolyurethane or silicone rubber. The PICC 30 is connected to thethree-way connector 15 by sliding its female hub 28 over the three wayconnector's 15 outlet port 21. The size of the female hub 28 is selectedso that it fits snugly on the outlet port 21 of the three-way connector15 creating a seal. It will not slide off without application of asubstantial force. The outlet port 21 provides communication between thethree-way connector 15 and the proximal end of the PICC 30. Disposed onthe insertion port 18 is a reclosable septum 41.

In order to make installation of the PICC 30 easier, a guidewire 35 isrun through the length of catheter 33. The guidewire 35 stiffenscatheter 33, which makes pushing it through a patient's venous systemeasier. The guidewire 35 preferably comprises a hydrophilically coated,twist-braided stylet. The guidewire 35 preferably has a handle 38 at itsdistal end. The handle 38 provides a gripping surface that is largerthan the guidewire 35. The large gripping surface makes guidewirehandling easier, which simplifies guidewire 35 movement andmanipulation, which reduces the amount of time it takes to install thecatheter. The handle 38 also acts as a stop to fix the position of theguidewire 35 in relation to the tip of the catheter 33.

The guidewire 35 passes through the reclosable septum 41 disposed on theinsertion port 18. The resilient nature of the latex rubber reclosableseptum 41 is such that it makes a water tight seal around the guidewire35. The guidewire 35 then travels through the three-way connector 15 andinto the catheter 30. When completely inserted, the guidewire handle 38will rest against the reclosable septum 41. Initial guidewire 35 lengthis selected such that when completely inserted, its proximal tip restsapproximately one-half to one centimeter from the catheter's 30 proximaltip. This provides additional protection from vein puncture orirritation by the guidewire 35. Once guidewire 35 is completely insertedin PICC 30, the catheter 33 is stiff enough to allow it to move througha vein without being impeded by any venous obstructions.

once the guidewire 35 is placed through the three-way connector 15, itcan slide its full length through the reclosable septum 41. Thereclosable septum 41 provides a slight resistance to movement of theguidewire 35. This resistance prevents the guidewire 35 from being movedtoo quickly through the three-way connector 15 and PICC 30. This isadvantageous since moving too quickly can cause patient discomfort andmay result in puncturing the vein. Once the wire is removed, thereclosable septum 41 forms a watertight barrier.

The flushing port 24 provides a means for connecting a syringe 50, asshown in FIG. 3, to the three-way connector 15. The lateral port 24 ispreferably disposed perpendicular to the insertion port 18 and outletport 21. Experimentation has shown that maintaining the lateral port 24perpendicularly to the insertion port 18 and outlet port 21 providesmany advantages. These advantages include insuring that the full forceof the injected flushing solution is absorbed by the side wall of thethree-way connector 15.

The syringe 50 is filled with flushing solution. Flushing solutions thatprovide the necessary characteristics include heparin and saline. Onceattached to the flushing port 24, the syringe 50 and its contents (theflushing solution) can be left attached until the PICC 30 is installedin its desired position. The normal operation of the syringe 50 willprevent any of the flushing fluid from entering the three-way connector15 until the syringe's plunger 53 is forced into the syringe's barrel56.

With reference to FIG. 3, the method of installing a PICC 30 in apatient will be discussed. In this discussion, the adjustabilityadvantages of the invention will be described. Prior to installation,the catheter guidewire flushing apparatus 10 must be prepared. The firststep in preparing for installation is the flushing of the catheterguidewire flushing apparatus 10. The manner in which the syringe 50 isused to flush the catheter guidewire apparatus 10 has been describedabove. Flushing prior to installation allows the user to check forpatency. The user will know that the PICC 30 has been successfullyflushed when drops of flushing solution begin to emerge from thecatheter 33 tip.

The next preparation step is to determine how long the PICC 30 needs tobe in order for its tip to reach the desired location within thepatient. In order to determine this length, the user measures thedistance between the insertion site and the desired tip location. If thelength necessary for proper catheter 33 tip location is shorter than thelength of the catheter 33, the catheter 33 of the PICC 30 must betrimmed to the proper length.

The method of trimming the PICC 30 will now be discussed. It is notedthat prior to trimming, the guidewire 35 is placed in the PICC 30 suchthat the guidewire's 35 handle 38 rests against the reclosable septum41. The first step in trimming the catheter 33 is to withdraw theguidewire 35 through the reclosable septum 41 so that the guidewire 35is only within the necessary length of the PICC 30. After the properlength of guidewire 35 has been withdrawn, the catheter 33 portion ofthe PICC 30 can be trimmed using sterile scissors and being careful toavoid cutting the guidewire. Approximately one centimeter of catheter 33should remain that has no guidewire within it. The resulting catheterguidewire flushing apparatus 10 has a PICC 30 with a catheter 33 ofproper length. Because the guidewire 35 has been withdrawn from the PICC30, the guidewire 35 handle 38 will no longer rest against thereclosable septum 41 and a portion of the guidewire 35 will no longer bewithin either the three-way connector 15 or the PICC 30. This is clearlyshown in FIG. 3.

After trimming the catheter 33, but immediately prior to installation,the catheter guidewire apparatus 10 may be flushed again. Flushing priorto installation allows the user to recheck catheter patency and canremove any residue created during catheter 33 trimming.

As discussed above, traditional catheter guidewire flushing apparatus'were difficult, if not impossible, to flush when excess guidewireemerged from the PICC 30. In the catheter guidewire flushing apparatus10 of the invention, however, the provision of flushing port 24 allowsthe catheter guidewire apparatus 10 to be flushed even though theguidewire 35 has been slightly withdrawn from the PICC 30. Thus, evenafter trimming, the peripherally inserted catheter can be installed in apatient with the flush feature intact.

It may be necessary to flush the catheter guidewire flushing apparatus10 during insertion to aid in installation. When the PICC 30 is flushedduring installation, the flushing solution will act to slightly move thecatheter 33, thereby allowing it to move past any venous obstruction.Flushing during installation can also remove any blood that mayaccumulate inside the lumen of the PICC 30.

Once installed in the patient, the guidewire 35 can be left in the PICC30 to verify its placement. This verification will take placeradiographically. After this verification, if it was desired, theguidewire 35 must be removed from the PICC 30. In order to remove theguidewire 35, the guidewire's 35 handle 38 is pulled. If any resistanceis felt, the PICC 30 should be flushed. As discussed above, the flushingsolution lubricates the guidewire 35, thereby making removal mucheasier. The provision of a separate flushing port 24, unlike traditionalguidewire flushing apparatus, allows the flushing to take place withoutany guidewire 35 manipulation, allows for flushing to take place at anytime, without having to reattach a syringe containing flushing solution,and avoids the possibility of puncturing a patient's vein or organ.

We claim:
 1. A method of installing a peripherally installed centralcatheter comprising:attaching a connector to a catheter; inserting aguidewire through the connector and into the catheter; filling a syringewith a flushing solution; attaching the syringe to a port on theconnector; depressing a plunger in the syringe such that an amount ofthe flushing solution from the syringe enters the connector and thecatheter, thereby flushing the catheter; determining the catheter'sdesired length; withdrawing the guidewire from the catheter such thatthe guidewire resides in a majority of the catheter's desired lengthwithout detaching the syringe; trimming the catheter so that only thecatheter's desired length remains; advancing the catheter into apatient; depressing the plunger in the syringe again such that anadditional amount of the flushing solution from the syringe enters thecatheter, thereby flushing the catheter and lubricating the guidewire;and withdrawing the guidewire from the catheter and the connector. 2.The installation method of claim 1 further comprising the step ofdepressing the plunger in the syringe while advancing the catheter intothe patient such that an additional amount of the flushing solution fromthe syringe enters the catheter to help ease the guidewire past anobstruction in the patient.
 3. The installation method of claim 1further comprising the step of depressing the plunger in the syringeafter trimming the catheter such that an additional amount of theflushing solution from the syringe enters the catheter.
 4. A method ofinstalling a catheter comprising:attaching a connector to a catheter;inserting a guidewire through the connector and into the catheter;filling a syringe with a flushing solution; attaching the syringe to aport on the connector; depressing a plunger in the syringe such that anamount of the flushing solution from the syringe enters the connectorand the catheter, thereby flushing the catheter; determining thecatheter's desired length; withdrawing the guidewire from the cathetersuch that the guidewire resides in a majority of the catheter's desiredlength without detaching the syringe; trimming the catheter so that onlythe catheter's desired length remains; advancing the catheter into apatient; depressing the plunger in the syringe again such that anadditional amount of the flushing solution from the syringe enters thecatheter, thereby flushing the catheter and lubricating the guidewire;and withdrawing the guidewire from the catheter and the connector. 5.The installation method of claim 4 further comprising the step ofdepressing the plunger in the syringe while advancing the catheter intothe patient such that an additional amount of the flushing solution fromthe syringe enters the catheter to help ease the guidewire past anobstruction in the patient.
 6. The installation method of claim 4further comprising the step of depressing the plunger in the syringeafter trimming the catheter such that an additional amount of theflushing solution from the syringe enters the catheter.
 7. A method ofinstalling a catheter in a patient comprising:connecting a syringecontaining flushing solution to a flushing port of a connector, saidconnector attached to said catheter at an outlet port and having aguidewire passing through said connector and through said catheter'slength; depressing a plunger in said syringe such that an amount of saidflushing solution from said syringe enters said connector and saidcatheter, thereby flushing said catheter; determining said catheter'sdesired length; withdrawing said guidewire from said catheter such thatsaid guidewire resides in a majority of said catheter's desired lengthwithout detaching said syringe; trimming said catheter so that only saidcatheter's desired length remains; and inserting said catheter into thepatient.
 8. The method of claim 7 wherein said inserting said catheterstep further comprises the steps of depressing said plunger in saidsyringe such that an additional amount of said flushing solution enterssaid connector and said catheter, thereby floating said catheter past anobstruction in said patient.
 9. The method of claim 7 further comprisingthe step of removing said connector from said catheter.
 10. The methodof claim 7 further comprising the steps of:withdrawing said guidewirefrom said catheter and from said connector after inserting saidcatheter; and removing said connector from said catheter.
 11. The methodof claim 7 further comprising the step of withdrawing said guidewirefrom said catheter and said connector.
 12. The method of claim 11further comprising the steps of:removing said syringe from said flushingport; and connecting a fluid infusing device to said flushing port. 13.The method of claim 12 further comprising the step of administeringfluid from said fluid infusing device to said patient.
 14. A method ofinstalling a catheter in a patient comprising:depressing a plunger of asyringe containing flushing solution, said syringe connected to aflushing port of a connector, said connector attached to said catheterand having a guidewire passing through said connector and through saidcatheter's length such that an amount of said flushing solution fromsaid syringe enters said connector and said catheter, thereby flushingsaid catheter; determining said catheter's desired length; withdrawingsaid guidewire from said catheter such that said guidewire resides in amajority of said catheter's desired length without detaching saidsyringe; trimming said catheter so that only said catheter's desiredlength remains; and inserting said catheter into the patient.
 15. Themethod of claim 14 wherein said inserting said catheter step furthercomprises the step of depressing said plunger in said syringe such thatan additional amount of said flushing solution enters said connector andsaid catheter, thereby floating said catheter past an obstruction insaid patient.
 16. The method of claim 14 further comprising the stepsof:withdrawing said guidewire from said catheter and said connectorafter inserting said catheter; and removing said connector from saidcatheter.
 17. The method of claim 14 further comprising the step ofwithdrawing said guidewire from said catheter and said connector.
 18. Amethod of installing a catheter in a patient comprising:determining saidcatheter's desired length, said catheter attached to a three-wayconnector at an outlet port of said catheter and having a guidewirepassing through said three-way connector and said catheter; withdrawingsaid guidewire from said catheter such that said guidewire resides in amajority of said catheter's desired length; trimming said catheter sothat only said catheter's desired length remains; connecting a syringecontaining flushing solution to a flushing port of said three-wayconnector; inserting said catheter into the patient; and depressing aplunger in said syringe such that an amount of said flushing solutionfrom said syringe enters said connector and said catheter, therebyflushing said catheter and floating said catheter past an obstruction insaid patient.